Official Title

Investigation of the Changes of Brain Structure and Function in Premature Ejaculation Patients and the Effects of Dapoxetine on Central Neural Activity in Premature Ejaculation Patients
  • Phase

    N/A
  • Study Type

    Interventional
  • Status

    Unknown status
  • Study Participants

    100
Lifelong premature ejaculation (LPE) is a common male sexual dysfunction with a high prevalence in global. Up to now, the etiology of LPE remains unclear. In recent years, dapoxetine, a highly potent serotonin-transporter inhibitor, has been used for treating premature ejaculation. However, the underlying mechanism of dapoxetine was unknown. Recently, with widespread use of neuroimaging techniques, like positron emission tomography and magnetic resonance imaging (MRI) in basic science, researchers can acquire human data on cerebral base of human sexual behavior, not only in normal subjects but also in patients with sexual dysfunction. Therefore, in order to further understand the biological mechanism of LPE and the brain targets of dapoxetine, the present study would investigate the brain changes of LPE and the effect of dapoxetine on brain activation by using MRI technology.
Study Started
Jul 10
2018
Primary Completion
Dec 31
2018
Anticipated
Study Completion
Dec 31
2018
Anticipated
Last Update
Aug 24
2018

Drug Dapoxetine Hydrochloride Tablet

oral one dapoxetine hydrochloride tablet before MRI scan

Drug Placebo Tablet

oral one placebo tablet before MRI scan.

Placebo Placebo Comparator

In this group, patients received placebo tablet before MRI scan.

Dapoxetine Active Comparator

In this group, patients received one dapoxetine hydrochloride tablet before MRI scan.

Criteria

Inclusion Criteria:

right-handed male Chinese volunteers
intravaginal ejaculatory latency time within 1 min
premature ejaculation diagnostic tool score >11 for patients, but <5 for each control.
patients who never received dapoxetine hydrochloride or other SSRI drugs

Exclusion Criteria:

smokers
had medical,neurological or psychiatric disorders
had alcohol, nicotine, or drug abuse
received any treatment at least 2 weeks before the experiment
No Results Posted